Novametrix
Novametrix Transcutaneous CO2 and O2 Monitors
Model 860 TCO2M Transcutaneous CO2 and O2 Monitor Users Manual
Users Manual
108 Pages
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Page 1
TCO2M
®
Transcutaneous CO2/O2 Monitor
User’s Manual Model 860
October 4, 1996 Catalog No. 6590-23-00
March 25, 1997 Catalog No. 6590-23-01
Copyright ©1997. Novametrix Medical Systems Inc. 5 Technology Drive Wallingford, Connecticut, U.S.A. 06492 All rights reserved.
Revision History 04-Oct-96 Release Version Rev.00 25-Mar-97 Revision 01
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Guarantee
Equipment manufactured or distributed by Novametrix Medical Systems Inc., is fully guaranteed, covering materials and workmanship, for a period of one year from the date of shipment, except for certain disposable products and products with stated guarantees other than one year. Novametrix reserves the right to perform guarantee service(s) at its factory, at an authorized repair station, or at the customer’s installation. Novametrix’ obligations under this guarantee are limited to repairs, or at Novametrix’ option, replacement of any defective parts of our equipment, except fuses, batteries, and calibration gasses, without charge, if said defects occur during normal service. Claims for damages during shipment must be filed promptly with the transportation company. All correspondence concerning the equipment must specify both the model name and number, and the serial number as it appears on the equipment. Improper use, mishandling, tampering with, or operation of the equipment without following specific operating instructions will void this guarantee and release Novametrix from any further guarantee obligations. Call toll free: 1-800-243-3444 To Call Direct: (203) 265-7701 Facsimile (203) 284-0753 http://www.novametrix.com
Caution: Federal (U.S.A.) law restricts this device to sale, distribution, or use by or on the order of a licensed medical practitioner. Copyright 1997. Novametrix Medical Systems Inc. 5 Technology Drive, Wallingford, Connecticut, 06492. This document contains information which is proprietary and the property of Novametrix Medical Systems Inc., and may not be reproduced, stored in a retrieval system, translated, transcribed, or transmitted, in any form, or by any means, without prior explicit written permission from Novametrix Medical Systems Inc.
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Table of Contents Revision History ... iii Table of Contents ... v Introduction ... 1 About this manual ... 1 Indications for Use ... 1 Summary of features ... 2 Principles of Operation ... 2 Oxygen ... 2 Carbon Dioxide ... 2 Local Power ... 3 Technical Description ... 3 Safety ... 5 Patient Safety ... 5 Contraindications ... 6 Warnings ... 6 Cautions ... 7 Quick Start Guide ... 9 Connect Sensor ... 9 Power Up ... 10 Calibrator Setup ... 10 Calibration ... 10 Alert Limits ... 10 Apply to Patient ... 10 Handling Alerts ... 10 Removal from Patient ... 10 Monitor Shutdown ... 10 System Overview ... 11 TCO2M Monitor Front Panel ... 11 or Power ... 11 Low Bat ... 11 AC ON ... 11 Two Minute Silence ... 12 Audio key ... 12 Audio Icon ... 12 Alert Reset ... 12 Alert Icon ... 12 Softkeys ... 12 Event ... 12 Contrast ... 12 TCO2M Monitor Rear Panel ... 12 Symbols ... 13 Equipotentiality ... 13 Ground ... 13
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Table of Contents
Dangerous Voltage ... 13 Patient Isolation ... 13 Attention ... 13 Mains Fuse ... 13 Mains Power ... 13 TCO2M Monitor Display ... 13 Transcutaneous Sensor Overview ... 14 Select sensor ... 14 Connect sensor ... 14 TCO2M Calibrator, Model 868 ... 14 Setting up the Calibrator ... 15 Disconnecting Gas Cylinders ... 16 Connect the calibrator ... 16 Operating the Monitor ... 17 TCO2M Power-up ... 17 Power On/Off ... 17 AC/Battery operation ... 17 AC Line Power ... 18 Battery Power ... 18 Operating on battery ... 18 Low battery alert ... 18 Charging the battery ... 18 Long Term Storage ... 18 Battery replacement ... 18 Monitoring CO2 and O2 Tension ... 19 Sensor Stabilization ... 19 Carbon Dioxide and Oxygen Alerts ... 19 Sensor Temperature Alerts ... 19 PtcCO2 Display Values ... 19 Menu Operation and Setup ... 21 Menu Structure ... 21 LIMIT - CO2 and O2 Alert Limits ... 21 Set Alert Limits ... 22 Auto Alert Limits ... 23 Limit Alerts ... 23 TRND - Real time trend displays ... 24 Real Time Trend ... 24 Show CO2 /O2/LP ... 24 Set Trend Time ... 24 Set CO2/O2 scale ... 25 Local Power (LP and LPR) ... 26 TRND - Trend Page (stored trend memory) displays ... 27 Show trend page ... 28 Moving in trend ... 28 Select trend page parameter ... 29 Select trend scale ... 29 Show histogram ... 29 Erase trend memory ... 30 Trend Data Compression ... 31 CAL - Sensor calibration ... 31 Calibrate sensor ... 31 Set temperature ... 32
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Site Timer ... 33 Reset site timer ... 33 Adjust site timer ... 34 Last Calibration information ... 35 DELAY - Suppress limit alerts ... 35 Set Alert Delay ... 35 Cancel Alert Delay ... 36 LITE - Display brightness ... 36 AUDIO - Adjust alert volume ... 36 Sensor Calibration ... 37 Sensor Calibration with the TCO2M Calibrator Model 868 ... 37 Manual Calibration of the O2 Sensor ... 39 O2 Sensor Initial Calibration ... 39 O2 Sensor Recalibration ... 40 Apply Sensor to Patient ... 43 Sensor Site Selection ... 43 Sensor to Patient Application ... 44 Removing the Sensor from the Patient ... 45 Combination O2/CO2 Sensor ... 47 Sensor Identification ... 47 Sensor Construction ... 47 Sensor Operation ... 47 Membrane Schedule ... 47 4474-00 Sensor Membraning Procedure ... 48 Long Term Combination Sensor Storage ... 50 Cleaning the Combination Sensor face ... 50 4474-39 Sensor Membraning Procedure ... 51 Carbon Dioxide Sensor ... 55 CO2 Sensor Construction ... 55 CO2 Sensor Operation ... 55 Membrane Schedule ... 55 CO2 Sensor Membraning Procedure ... 55 Long Term CO2 Sensor Storage ... 57 Cleaning the CO2 Sensor face ... 57 Oxygen Sensor ... 59 O2 Sensor Construction ... 59 O2 Sensor Operation ... 59 Membrane Schedule ... 59 Cleaning and Membraning the O2 Sensor face ... 59 Long Term O2 Sensor Storage ... 61 Advanced Controls and Features ... 63 Display Menu ... 63 Temperature or Power Display ... 63 Limit Display ... 64 Display Colors ... 64 Display Units ... 65 System Menu ... 65 Serial Out ... 65 Set Clock ... 66 Site Timer (Maximum Duration) ... 66 Metabolic Correction Factor ... 67 Barometric pressure determination ... 67
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Table of Contents
Alerts Menu ... 68 Latch Alerts ... 68 10 second Alert Delay Option ... 69 Retain Alert Limits ... 69 Red Alert Bar ... 69 Audio Menu ... 70 Allow Audio Off ... 70 Keyclick Volume ... 70 Sensor Menu ... 71 Restoring factory defaults settings ... 71 External Devices ... 73 NovaCARD ... 73 NovaCARD Configuration ... 74 Using NovaCARD ... 74 Analog Output Module ... 75 Connecting the Analog Output Module ... 75 Calibrating an External Recorder ... 76 Printer ... 77 Setup Printer ... 77 Setup TCO2M ... 78 Types of Printouts ... 78 Displayed Trend printout ... 78 Compressed Trend printout ... 79 Zoom Trend printout ... 79 Stopping a printout ... 80 Trend Printout ... 81 Tabular Printout ... 85 NovaCOM ... 86 NovaCOM Configuration ... 86 NovaCOM Data Format ... 86 Real Time ... 86 Trend Dump ... 87 Date and Time ... 89 Clear Trends ... 89 Exit Command ... 89 Flexport ... 90 Terminal ... 90 Maintenance ... 91 Cleaning and Disinfecting ... 91 Monitor ... 91 Sensors ... 91 Calibrator ... 91 Battery Maintenance ... 92 Long Term Storage ... 92 Charging the battery ... 92 Battery replacement ... 92 Line Cord ... 92 Fuses ... 92 Specifications ... 95 Monitor Model 860 ... 95 Sensors ... 96 Gas Calibrator Model 868 ... 96 Guarantee ... 97 Accessories ... 99
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Introduction The TCO2M® Transcutaneous CO2/O2 Monitor, Model 860 is designed to be an easyto-operate stand-alone transcutaneous monitoring system. It is intended to be used in patient monitoring environments by technically skilled clinical personnel.
About this manual This manual is written for clinical personnel using the TCO2M® Transcutaneous CO2/O2 Monitor, Model 860, the Transcutaneous Calibrator, Model 868, and the transcutaneous sensors and accessories intended for use with the monitor and calibrator from Novametrix Medical Systems Inc. This document contains information which is proprietary and the property of Novametrix Medical Systems Inc., and may not be reproduced, stored in a retrieval system, translated, transcribed, or transmitted, in any form, or by any means, without the prior explicit written permission of Novametrix Medical Systems Inc. Novametrix reserves the right to change specifications without notice. TCO2M and NOVADISK are registered trademarks, and NovaCARD and NovaCOM are trademarks of Novametrix Medical Systems Inc.
Indications for Use The TCO2M Transcutaneous CO2/O2 Monitor, Model 860 is indicated for use as a trend monitor for CO2 and O2 tension at the skin surface for neonates and adults as an adjunct to arterial CO2 and O2 blood gas measurements. This equipment is not a blood gas device. Regulatory review (U.S.A.) of safety and effectiveness for transcutaneous oxygen monitors is not required at this time. However, the oxygen-monitoring portion of this device has been found to be substantially equivalent to devices marketed in interstate commerce prior to May 28, 1976.
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Summary of features
Summary of features The TCO 2 M Transcutaneous CO 2 /O 2 Monitor provides reliable, continuous measurement, displays and alerts for transcutaneous oxygen tension (PtcO 2 ), transcutaneous carbon dioxide tension (PtcCO2) and sensor temperature. Sensor heater power is also trended and can be displayed. The monitor’s real time graphic onscreen trends along with the numeric values provide truly continuous CO2 and O2 monitoring. A simple menu system with helpful messages guides the user through setup and alert conditions. Built-in 24-hour trend memory with graphic and histogram displays are available for viewing of patient history. The lightweight portable monitor can operate from AC power or from its internal battery. Sensor calibration is quick, fully automatic, barometric pressure compensated, and uses a true two-point method for accurate calibrations. The Calibrator is completely powered from the Monitor and the sensor can be inserted and removed from the calibrator with a single hand. TCO2M accepts combination CO2/O2 sensors as well as CO2 only or O2 only sensors for optimum versatility. Sensors provide superior performance, fast response, are rugged, reliable and can be membraned in seconds. An automatic site timer enhances patient safety.
Principles of Operation Oxygen
Transcutaneous oxygen is measured with an oxygen sensor consisting of two parts; 1) a modified Clark-type polarographic electrode, a silver anode and platinum cathode, electrolyte and an oxygen permeable membrane, and 2) a heating section with two precision thermistors for measuring and controlling the sensor temperature. When the sensor is subjected to oxygen, the oxygen molecules diffuse through the membrane and create an electro-chemical reaction which causes current to flow through the cathode. An amplifier connected to the cathode measures current flowing and converts it to a value proportional to the oxygen tension at the sensor/membrane interface. This is PtcO2 and is displayed as a O2 value (in either mmHg or kPa as selected by the user).
Carbon Dioxide
Transcutaneous carbon dioxide is measured with a sensor that utilizes a unique pH electrode based on the Stow-Severinghaus principle. The carbon dioxide sensor is composed of two parts; 1) a carbon dioxide sensor consisting of a pH electrode, reference electrode, electrolyte and a carbon dioxide permeable membrane, and 2) a heating section with two precision thermistors for measuring and controlling the sensor temperature. When the sensor is subjected to carbon dioxide, the carbon dioxide molecules diffuse through the membrane and react with the electrolyte. This reaction alters the pH of the electrolyte solution, which in turn changes the voltage across the pH and reference sensors. Since carbon dioxide is the only gas that can affect the pH of the electrolyte, there is a direct correlation between pH and the amount of CO2 present. This relationship is expressed by the Henderson-Hasselbach
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Technical Description
equation:
pH = pKa + log
HCO3 0.03 pCO2
An amplifier measures this voltage change and converts it to a value corresponding to the carbon dioxide tension at the sensor/membrane interface. This is PtcCO2 and is displayed as a CO2 value (in either mmHg or kPa as selected by the user). Local Power
Local Power is the measure of electrical power, measured in milli-watts (mW), required by the sensor to maintain the selected sensor temperature setting. The Local Power value is proportional to the blood flow beneath the sensor site. Because the sensor set temperature is above blood temperature, blood flowing past the sensor site provides a cooling action. As blood flow (and its associated cooling action) increases, the sensor requires more power to maintain its temperature setting and the LP value increases. Conversely, as blood flow decreases, sensor heater power and LP also decrease. Abrupt changes in PtcO2 coupled with significant LP changes may indicate reduced blood flow at the sensor site, while abrupt changes in PtcO2 unaccompanied by significant LP changes may indicate consistent blood flow but a change in PaO2. Important: Sensor heater power requirements (LP) are also influenced by body temperature and ambient temperature changes. Body temperature changes tend to be gradual over time and produce minor changes in LP. Ambient temperature changes from air-conditioners, patient warmers, radiant heaters, etc., can have significant effects on the LP value. If monitoring the LP value, it may be necessary to insulate the sensor from ambient temperature changes with a light covering such as a bedsheet, or with material designed to reflect radiant heat energy.
Technical Description Per requirements of IEC 601-1, TCO2M is classified as class I equipment, internally powered, with type BF applied part, and IPX0. The TCO 2 M Transcutaneous CO 2 /O 2 Monitor, Model 860, contains no user serviceable parts. Refer servicing to qualified service personnel. See “Accessories” on page 99 for listings of the Service Manual and Service Test kit for use by technical personnel. Transport and storage conditions: -10 to +55° C (14-131° F) < 90% relative humidity non-condensing. Operating conditions:10-40° C (50-104° F).
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Safety Patient Safety • The location of the sensor on the patient should be changed periodically to minimize the risk of heat induced skin damage. The risk of such skin damage is dependent upon the sensor temperature, duration of application and physiological parameters including local perfusion, body temperature, and skin thickness. • TCO2M monitor has electrically isolated inputs. Patient leakage current flowing from the instrument to ground is limited to less than 10 µA at 120 V, 60 Hz. Patient isolation is greater than 10 MΩ, 2500 V rms at 60 Hz. For maximum patient and operator safety, the following procedures are recommended; •Keep the TCO2M and its accessories clean. •Do not operate the TCO2M when it is wet due to spills or condensation. •Do not touch the patient while making adjustments on the TCO2M monitor. •Whenever possible, the TCO2M monitor should be connected to the same circuit as other equipment in use on the same patient. Outlets that are on the same circuit can be identified by your hospital’s engineering department. • In areas where electromagnetic devices (i.e., electrocautery) are used, patient monitoring may be interrupted due to electromagnetic interference. Electomagnetic fields up to 3 V/m will not adversely affect system performance. • The PtcCO2 display reading (CO2) is factory set to reflect the metabolic factor for pCO2 and the value is corrected only during patient monitoring- not during calibration. See “PtcCO2 Display Values” on page 19. • Components of this product and its accessories which have patient contact are latex free. • Connect only Novametrix supplied transcutaneous sensors and gas calibrators to the TCO2M Model 860 monitor front panel input connectors. Refer to “Accessories” on page 99 for listings and catalog numbers.
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Contraindications
Contraindications • In patients who are hemodynamically compromised, transcutaneous gas values may no longer reflect arterial gas values due to changes in blood flow to the tissue. • Patients with extremely sensitive skin should be carefully evaluated prior to monitoring as sensor heat or adhesive ring application may cause skin irritation. Skin irritation due to the adhesive ring can be minimized by loosening the adhesive with alcohol or water prior to its removal from the patient. • HALOTHANE INTERFERENCE. Halothane is the only known anesthetic gas affecting the reliability of transcutaneous oxygen (PtcO2) measurement as demonstrated in in-vitro testing of the Transcutaneous Combination O2/ CO2 Sensor (PN:4474). The affect of halothane on transcutaneous oxygen measurements in-vivo has not been determined. Halothane does not affect the transcutaneous carbon dioxide (PtcCO2) measurement of the Transcutaneous Combination O2/CO2 Sensor. No known anesthetic gasses affect the performance of the Transcutaneous Oxygen Sensor (PN:6754) or the Transcutaneous Carbon Dioxide Sensor (PN:6752). • PtcO2 levels in excess of 150 mmHg may cause drift of PtcCO2 portion of the 4474-00 Combination O2/CO2 Sensor using an 8900 Split Membrane NOVADISK. This drift is not experienced with the 4474-39 Combination O2/CO2 Sensor and 8575 NOVADISK, nor with the Transcutaneous Oxygen Sensor (PN:6754) or the Transcutaneous Carbon Dioxide Sensor (PN:6752).
Warnings WARNING: Indicates a potentially harmful condition that can lead to personal injury.
• Explosion Hazard: Do NOT use the TCO2M in the presence of flammable anesthetics. Use of this instrument in such an environment may present an explosion hazard. • Electrical Shock Hazard: Always turn the monitor off before cleaning it. Do NOT use a damaged sensor or one with exposed electrical contacts. Do NOT remove covers or panels. Refer servicing to qualified service personnel. • Failure of Operation: If the monitor fails to respond as described, do not use it until the situation has been corrected by qualified personnel. • Fire Hazard: The TCO2M and its sensors should not be exposed to elevated oxygen levels at elevated pressures. Use of this instrument in such an environment may present a fire hazard. • For installations where the integrity of the external protective earth conductor arrangement is in doubt, the equipment should be operated from its internal battery only.
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Cautions
• No user serviceable parts inside. Refer servicing to qualified service personnel.
Cautions CAUTION: Indicates a condition that may lead to equipment damage or malfunction.
• Federal (U.S.A.) law restricts this device to sale, distribution, or use by or on the order of a licensed medical practitioner. • No tension should be applied to the sensor cable. • Avoid storing the monitor and sensors at temperatures less than -10° C or greater than +55° C (<14° F or >131° F). • Do NOT immerse the monitor or sensors in liquids. • Do NOT sterilize the monitor or the sensors. • Electric Shock Hazard. Always turn the monitor off before cleaning it. Do NOT use a damaged sensor or one with exposed electrical contacts. Do NOT remove covers or panels. Refer servicing to qualified service personnel. • Connect the line cord only to a grounded hospital-grade outlet. • For continued protection against fire hazard, replace fuses only with those of the same type and rating. • No user serviceable parts inside. Refer servicing to qualified service personnel. • Operate at temperatures between +10° C to +40° C (50-104° F), < 90% relative humidity (non-condensing).
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Quick Start Guide This section summarizes and highlights the key steps and processes required to properly configure the TCO2M® monitor for operation, connect and calibrate the sensor, apply the sensor to the patient, handle any associated alerts, and remove the sensor from the patient. This section is an adjunct to other sections of this manual where these steps or processes are explained in more detail. Refer to the appropriate sections for more information. Use of equipment other than mentioned here may yield different results.
Calibrator connection Sensor connection
Sensor Port Connect to TCO2M
Connect Sensor
1
Attach an appropriate sensor to the TCO2M’s front panel connector. The sensor will “click” into place when properly installed. Ensure the sensor is in good physical condition and that the NOVADISK membrane assembly is intact and clean-use an alcohol wipe if needed.
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3 Quick Start Guide
Power Up
2
Press the
key to turn the TCO2M on.
AC ON illuminates if the monitor is connected to the AC line and the rear panel power switch is set to “|”. This also causes the internal battery to charge. A battery icon appears on the display if the monitor is operating from its internal battery.
Calibrator Setup
3
The base menu display appears after the power-up and self-test messages.
4
Press the
5
Connect the Model 868 Calibrator to the small connector on the monitor’s front panel.
(Contrast) key to adjust the display for optimum viewing.
Ensure that the gas cylinders are properly installed. They are color coded to make it easy. Check that the cylinders are not empty. Both gauges should be registering pressure. If using an O2 only sensor, the Model 868 Calibrator is not required.
Calibration
6
Place the sensor into the Calibrator’s Sensor Port. If using an O2 only sensor, refer to the appropriate section of the manual for calibration.
7
Press the CAL softkey. Verify the calibration settings, including site timer duration and temperature are correct. Press START to begin calibration. If calibration settings need adjustment, press SET to adjust them. Calibration will not begin if the sensor is not yet up to operating temperature. Wait until temperature is achieved and try calibration again.
8
When the TCO2M beeps and the CALIBRATION DONE message appears, press RUN and remove the sensor from the calibrator.
Alert Limits
9
Verify the alert limits are properly set. If needed, press LIMITS to adjust.
Apply to Patient
10 Attach an adhesive ring to the sensor face, apply a drop of contact gel, and apply the sensor to a properly prepared site.
Handling Alerts
11 To temporarily silence an audible alert and to keep the red alert bar from flashing for two minutes, press the key. 12 Once the parameter comes back within limits (or limits are widened), press ALERT RESET to clear the displayed message and flashing limit display.
Removal from Patient
13 To remove the sensor from the skin, gently peel the adhesive ring from the skin. Wiping the ring with water or alcohol will loosen the adhesive and aid removal.
Monitor Shutdown
14 To turn the TCO2M off, press the
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System Overview This section provides an overview of the TCO2M Transcutaneous Monitoring System including the Model 860 Monitor, Model 868 Calibrator, and transcutaneous sensors.
TCO2M Monitor Front Panel The TCO2M Monitor, Model 860 front panel includes dedicated function keys, menu dependent “softkeys” and illuminating icon symbols. A Red Alert Bar, sensor, and Model 868 Calibrator input connections also appear on the front panel. Red Alert Bar
Sample Display
TCO2M Calibrator Model 868 connection Sensor input
or
Power
Low Bat
Turn the monitor power on and off. Icon illuminates red when operating on battery power and 15 minutes of battery life remain. • A similar icon appears in the display when the monitor is running on battery power and gives a visual indication of the charge left on the battery.
AC ON
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Icon illuminates green when the monitor is connected to AC power and the rear panel power switch is set to “|” (ON). Also indicates the battery is charging.
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